A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Anemia Clinical Trial

Official title:

A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442793
• Other study ID #: ML20680
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2007
• Last updated: November 1, 2016
• Start date: May 2007
• Est. completion date: May 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: SFDA
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic renal anemia requiring dialysis;

• maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;

• adequate iron status.

Exclusion Criteria:

• previous epoetin treatment within 8 weeks prior to screening;

• failing renal graft in place;

• bleeding episode necessitating transfusion within 8 weeks prior to screening;

• poorly controlled hypertension;

• previous treatment with Mircera.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Epoetin beta
As prescribed, 3 times weekly
• methoxy polyethylene glycol-epoetin beta [Mircera]
0.4 micrograms/kg iv every 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hb response rate		Weeks 0-24	No
Primary	Change in Hb concentration between baseline and evaluation period		Months 4-6	No
Secondary	Hb over time		Throughout study	No
Secondary	Time to Hb response		Throughout study	No
Secondary	RBC transfusions		Weeks 0-24	No
Secondary	AEs, laboratory parameters, vital signs		Throughout study	No
Secondary	Serum concentration of Mircera		Throughout study	No